CN111489822A - Therapeutic drug monitoring result interpretation system - Google Patents
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Abstract
The embodiment of the invention provides a therapeutic drug monitoring result interpretation system, which comprises: a comparison and judgment module, configured to: comparing the therapeutic agent monitoring result with at least one preset first reference concentration range; and/or obtaining at least one preset statistical result according to the therapeutic drug monitoring result, and comparing the preset statistical result with a corresponding preset second reference concentration range to obtain a therapeutic drug monitoring comparison result; a report generation module to: and generating a therapeutic drug monitoring result interpretation report according to the therapeutic drug monitoring comparison result and a corresponding preset report template. The therapeutic drug monitoring result interpretation system provided by the embodiment of the invention obtains the therapeutic drug monitoring comparison result by performing preset comparison, and then generates the therapeutic drug monitoring result interpretation report according to the therapeutic drug monitoring comparison result and the corresponding preset report template, thereby realizing standardization and automation of generation of the therapeutic drug monitoring result interpretation report and improving the generation efficiency.
Description
Technical Field
The invention relates to the technical field of data processing, in particular to a therapeutic drug monitoring result interpretation system.
Background
Therapeutic drug monitoring (TDM for short) refers to the process of observing the therapeutic effect of a drug, collecting blood of a patient at regular time (sometimes collecting urine, saliva and other liquids), measuring the concentration of the drug therein, and discussing the in vivo process of the drug, so as to individualize a drug administration scheme according to the specific situation of the patient, guided by the basic theory of pharmacokinetics and pharmacodynamics, by means of advanced analysis techniques and electronic computer means, and by using the principle and formula of pharmacokinetics. Thereby achieving satisfactory curative effect and avoiding toxic and side effects, providing valuable laboratory basis for diagnosis and treatment of drug excessive poisoning, and improving clinical medication from traditional experience mode to more scientific level.
The monitoring of therapeutic drugs belongs to the interdisciplinary department and relates to a plurality of disciplines such as drug analysis, pharmacology, inspection medicine, clinical medicine, pharmacogenetics, nursing science, informatics and the like. At present, the explanation of the monitoring result of the therapeutic drug mostly adopts a manual mode, which causes higher requirements on related medical personnel and low explanation efficiency of the monitoring result of the therapeutic drug.
Disclosure of Invention
To solve or at least partially solve the problems in the prior art, an embodiment of the present invention provides a therapeutic drug monitoring result interpretation system, including: a comparison and judgment module, configured to: comparing the therapeutic agent monitoring result with at least one preset first reference concentration range; and/or obtaining at least one preset statistical result according to the therapeutic drug monitoring result, and comparing the preset statistical result with a corresponding preset second reference concentration range to obtain a therapeutic drug monitoring comparison result; a report generation module to: and generating a therapeutic drug monitoring result interpretation report according to the therapeutic drug monitoring comparison result and a corresponding preset report template.
Further, the preset first reference concentration range comprises a treatment reference concentration range and a laboratory warning concentration; the preset statistical result comprises dose-related concentration, and the preset second reference concentration range corresponding to the dose-related concentration is a dose-related reference concentration range.
Further, the comparison and judgment module, before being configured to obtain the therapeutic monitoring comparison result, is further configured to: and if the therapeutic drug monitoring result is judged to be not in the therapeutic reference concentration range and/or the dose-related concentration is not in the dose-related reference concentration range, judging whether the therapeutic drug monitoring result is a steady-state concentration, if so, further calculating a ratio of the metabolite to the parent drug according to the therapeutic drug monitoring result, and comparing the ratio of the metabolite to the parent drug with the ratio range of the metabolite to the parent drug.
Further, the system also comprises a result analysis module; the comparison and judgment module is also used for sending the therapeutic drug monitoring and comparison result to the result analysis module; the result analysis module is used for acquiring a corresponding item to be analyzed according to the therapeutic drug monitoring and comparing result, analyzing the item to be analyzed to obtain a reason analysis result and a suggestion conclusion corresponding to the therapeutic drug monitoring and comparing result, and sending the reason analysis result and the suggestion conclusion to the report generation module.
Further, the therapeutic monitoring comparison result comprises a combined interval relationship formed by a first interval range obtained by comparing the therapeutic monitoring result with the therapeutic reference concentration range, the laboratory warning concentration and the lower detection limit, a second interval range obtained by comparing the dose-related concentration with the dose-related reference concentration range, and a third interval range obtained by comparing the metabolite-to-parent drug ratio with the metabolite-to-parent drug ratio range; and the items to be analyzed correspond to the interval combination relationship.
Further, the items to be analyzed include at least one of enzyme metabolism status, test items, compliance issues, drug combination status, historical TDM results, peak concentration, half-life, minimum inhibitory concentration, and drug metabolizing enzyme genotype.
Further, the preset report template comprises at least one of a standard statement field, a therapeutic drug monitoring comparison result description field, a therapeutic drug monitoring comparison result reason description field and a suggestion description field; wherein, the therapeutic drug monitoring and comparing result description field comprises a preset reference concentration range field and a relation description field.
Further, the report generation module is specifically configured to: acquiring the preset report template corresponding to the therapeutic drug monitoring comparison result; if the therapeutic drug monitoring comparison result comprises a therapeutic drug monitoring comparison result description field, determining the relation description field according to the therapeutic drug monitoring comparison result, and determining the therapeutic drug monitoring comparison result description field according to the preset reference concentration range field and the relation description field; if the therapeutic drug monitoring comparison result comprises a therapeutic drug monitoring comparison result reason description field, determining the therapeutic drug monitoring comparison result reason description field according to the reason analysis result; if the therapeutic drug monitoring comparison result comprises a recommendation description field, determining the recommendation description field according to the recommendation conclusion; and finally, automatically generating the therapeutic drug monitoring result explanation report according to the preset sequence among the fields in the preset report template.
Further, the system further comprises a patient information acquisition module, wherein the patient information acquisition module is used for acquiring the patient-related information related to the item to be analyzed and providing the patient-related information to the result analysis module for analysis.
Further, the report generation module is further configured to output a preset standard speech segment when the therapeutic drug monitoring result is not the steady-state concentration or other preset conditions.
According to the therapeutic drug monitoring result interpretation system provided by the embodiment of the invention, the therapeutic drug monitoring result is compared with at least one preset first reference concentration range, and/or at least one preset statistical result is obtained according to the therapeutic drug monitoring result, and the preset statistical result is compared with the corresponding preset second reference concentration range, so that the therapeutic drug monitoring comparison result is obtained, and a therapeutic drug monitoring result interpretation report is generated according to the therapeutic drug monitoring comparison result and the corresponding preset report template, so that the standardization and automation of the generation of the therapeutic drug monitoring result interpretation report are realized, and the generation efficiency is improved.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.
FIG. 1 is a schematic diagram of a therapeutic drug monitoring result interpretation system according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a therapeutic drug monitoring result interpretation system according to another embodiment of the present invention;
fig. 3 is a schematic view of a drug monitoring result interpretation process of the therapeutic drug monitoring result interpretation system according to an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the embodiment of the invention, the monitoring result of the therapeutic drug is taken as an example for introduction. The relevant medical terms involved are explained first below.
Treatment reference concentration range:
there is a range of drug concentrations for which the drug is most effective and safely acceptable when used for the prevention, treatment or diagnosis of a disease, i.e., a "treatment/diagnosis/prevention reference concentration range". The range name varies depending on the purpose of administration, but generally means a concentration range that is controlled to achieve the purpose of administration and to ensure the risk of administration to the patient, and sometimes is adjusted depending on the individual condition and diagnosis condition of the patient, and is not fixed. In treating a disease, this index correlates the steady-state trough concentration of the patient with the efficacy of the patient after administration, including the upper and lower limits of the drug concentration range. Concentrations below the lower limit are likely to be therapeutically ineffective; whereas above the upper concentration the tolerability is reduced or the therapeutic effect is unlikely to increase further. The therapeutic/diagnostic/prophylactic reference concentration range is an instructive, population-based range, and does not necessarily apply to all patients and all samples, and some patients may benefit better from being outside the reference concentration range. Similar terms also apply: reference range, normal range, valid range, etc.
Laboratory warning concentration:
the concentration of the medicine is higher than the concentration threshold value, and the medicine needs to be fed back to a doctor or needs to be acted by a relevant department immediately by a laboratory. Beyond this concentration, the benefit of the patient is not considered to exceed the potential risk associated with the drug, and depending on the patient's particular situation and the drug being monitored, at least increased attention to the risk of drug administration, and sometimes immediate intervention or protective measures, may be required. These alert concentrations are mostly reported as being poorly tolerated or poisoned, as well as the results of plasma drug concentration measurements. Similar terms also apply: critical value.
Dose-Related Concentration (DRC):
refers to the range of steady state trough concentrations of a drug that are theoretically expected for a given amount of usage. There is a corresponding relationship between this concentration and the dose. When the measured blood concentration of the patient is within the dose-related reference concentration range, the actual blood concentration of the patient is considered to correspond to the dose for the given drug regimen. It is considered that blood concentrations above or below this range suggest the potential for abnormal conditions resulting from non-given drug administration, such as poor compliance, lifestyle (e.g., smoking), drug interactions (including drug-food interactions, drug-disease interactions), genetic polymorphisms of drug metabolizing enzymes, or organ presence associated with drug excretion. Similar terms also apply: concentration/dose, dose/concentration, C/D, D/C, etc.
Metabolite to parent drug ratio (MPR):
MPR is defined narrowly as the ratio of metabolite to parent drug plasma concentration, broadly as the ratio of substance to parent drug that directly reflects the level of its metabolite, and is a direct indication of the activity of the drug's in vivo metabolic enzymes, where a metabolic enzyme may comprise a phase I metabolic enzyme (CYP family), a phase II metabolic enzyme (UGT, SU L T, COMT, NAT, GST, FMO, enzyme family), or a transport system related enzyme (P-gp).
Fig. 1 is a schematic structural diagram of a therapeutic drug monitoring result interpretation system according to an embodiment of the present invention. As shown in fig. 1, the system includes a comparison and judgment module 10 and a report generation module 20, wherein: the comparing and judging module 10 is configured to: comparing the therapeutic agent monitoring result with at least one preset first reference concentration range; and/or obtaining at least one preset statistical result according to the therapeutic drug monitoring result, and comparing the preset statistical result with a corresponding preset second reference concentration range to obtain a therapeutic drug monitoring comparison result; the report generation module 20 is configured to: and generating a therapeutic drug monitoring result interpretation report according to the therapeutic drug monitoring comparison result and a corresponding preset report template.
The therapeutic monitoring results interpretation system may be communicatively coupled to the HIS system to obtain therapeutic monitoring results for the patient. After the therapeutic drug monitoring result is obtained, the comparison and judgment module 10 of the therapeutic drug monitoring result interpretation system is used for comparing the therapeutic drug monitoring result with at least one preset first reference concentration range to obtain a therapeutic drug monitoring comparison result; or, obtaining at least one preset statistical result according to the therapeutic drug monitoring result, and comparing the preset statistical result with a corresponding preset second reference concentration range, thereby obtaining a therapeutic drug monitoring comparison result; or comparing the therapeutic drug monitoring result with at least one preset first reference concentration range, obtaining at least one preset statistical result according to the therapeutic drug monitoring result, and comparing the preset statistical result with a corresponding preset second reference concentration range, thereby obtaining a therapeutic drug monitoring comparison result.
The preset first reference concentration range, the preset statistical result and the preset second reference concentration range can be set according to actual conditions. In addition, the preset first reference concentration range and the preset second reference concentration range are not limited to be one value interval, and may be or include fixed values.
The report generation module 20 is configured to: and generating a therapeutic drug monitoring result interpretation report according to the therapeutic drug monitoring comparison result and a corresponding preset report template. A plurality of report templates can be preset and respectively correspond to different types of therapeutic drug monitoring comparison results. Such as template one when the therapeutic agent monitoring result is within the therapeutic reference concentration range, template two when the dose-related concentration exceeds the laboratory alert concentration, etc., thereby enabling the preset report template to be targeted and more clearly represent relevant content. The therapeutic drug monitoring result interpretation report can be output and printed after being generated.
According to the therapeutic drug monitoring result interpretation system provided by the embodiment of the invention, the therapeutic drug monitoring result is compared with at least one preset first reference concentration range, and/or at least one preset statistical result is obtained according to the therapeutic drug monitoring result, and the preset statistical result is compared with the corresponding preset second reference concentration range, so that the therapeutic drug monitoring comparison result is obtained, and a therapeutic drug monitoring result interpretation report is generated according to the therapeutic drug monitoring comparison result and the corresponding preset report template, so that the standardization and automation of the generation of the therapeutic drug monitoring result interpretation report are realized, and the generation efficiency is improved.
Further, based on the above embodiment, the preset first reference concentration range includes a treatment reference concentration range and a laboratory guarding concentration; the preset statistical result comprises dose-related concentration, and the preset second reference concentration range corresponding to the dose-related concentration is a dose-related reference concentration range.
In this embodiment, the comparing and determining module 10 is configured to: comparing the therapeutic drug monitoring result to a therapeutic reference concentration range and a laboratory warning concentration; and/or obtaining a dose-related concentration DRC according to the therapeutic drug monitoring result, and comparing the dose-related concentration DRC with a corresponding dose-related reference concentration range to obtain a therapeutic drug monitoring comparison result.
And if the measured blood concentration is within the treatment reference concentration range and the dose-related concentration DRC is within the dose-related reference concentration range, the measured concentration of the current dose of the drug taken by the patient is considered to be in accordance with the expectation. If the blood concentration is not in the treatment reference concentration range or the dose-related concentration DRC is not in the dose-related reference concentration range, the reasons for the abnormal results, such as liver and kidney function problems, infection, drug-drug interaction, drug-food interaction, drug administration compliance of patients and the like, need to be further analyzed according to data collected by medical history review.
Based on the above embodiments, the embodiment of the present invention provides a standardized path for interpretation of the monitoring result of the therapeutic agent by reasonably setting the preset first reference concentration range including the treatment reference concentration range and the laboratory guarding concentration, and the preset statistical result including the dose-related concentration.
Further, based on the above embodiment, the comparison and judgment module 10, before being configured to obtain the therapeutic monitoring comparison result, is further configured to: and if the therapeutic drug monitoring result is judged to be not in the therapeutic reference concentration range and/or the dose-related concentration is not in the dose-related reference concentration range, judging whether the therapeutic drug monitoring result is a steady-state concentration, if so, further calculating a ratio of the metabolite to the parent drug according to the therapeutic drug monitoring result, and comparing the ratio of the metabolite to the parent drug with the ratio range of the metabolite to the parent drug. If not, finishing the judgment and directly issuing a corresponding report.
Some drugs have metabolite to parent drug ratios, and some drugs do not. For example, for drugs with metabolites and TDM-detected blood levels, MPR can be calculated and metabolic phenotype of liver drug enzymes can be evaluated. For the drug with the ratio of the metabolite to the parent drug, when judging that the monitoring result of the therapeutic drug is not in the therapeutic reference concentration range and/or the dose-related concentration is not in the dose-related reference concentration range, and under the condition that the monitoring result of the therapeutic drug is confirmed to be the steady-state concentration, the ratio of the metabolite to the parent drug is further calculated according to the monitoring result of the therapeutic drug, and the ratio of the metabolite to the parent drug is compared with the ratio range of the metabolite to the parent drug. Thus, the therapeutic monitoring comparison is made from a comparison of the reference concentration range associated with the therapeutic reference concentration range and/or dose and a comparison of the metabolite to parent drug ratio range.
On the basis of the above embodiment, the embodiment of the invention further calculates the ratio of the metabolite to the parent drug for the drug with the ratio of the metabolite to the parent drug, and compares the ratio of the metabolite to the parent drug with the ratio range of the metabolite to the parent drug, thereby providing an important clue for efficiently finding the cause of the abnormality.
Fig. 2 is a schematic structural diagram of a therapeutic drug monitoring result interpretation system according to another embodiment of the present invention. Further, based on the above embodiment, the system further includes a result analysis module 30; the comparison and judgment module 10 is further configured to send the therapeutic drug monitoring and comparison result to the result analysis module 30; the result analysis module 30 is configured to obtain a corresponding item to be analyzed according to the therapeutic drug monitoring comparison result, obtain a reason analysis result and a suggestion conclusion corresponding to the therapeutic drug monitoring comparison result by analyzing the item to be analyzed, and send the result and the suggestion conclusion to the report generation module 20.
After the comparison and judgment module 10 sends the therapeutic drug monitoring and comparison result to the result analysis module 30, the result analysis module 30 obtains a corresponding item to be analyzed according to the therapeutic drug monitoring and comparison result, analyzes the item to be analyzed to obtain a reason analysis result and a suggestion conclusion corresponding to the therapeutic drug monitoring and comparison result, and sends the reason analysis result and the suggestion conclusion to the report generation module 20. Different items to be analyzed can be preset according to the monitoring and comparison result of the therapeutic drugs so as to accelerate the analysis process.
The result analysis module 30 may perform reason analysis and corresponding suggestion on the monitoring and comparing result of the therapeutic drug by methods such as ratio evaluation of metabolite to parent drug, liver and kidney function evaluation of patient, same-drug evaluation of patient, metabolic gene phenotype evaluation of patient, and other preset factor evaluation, and send the reason analysis result and suggestion conclusion to the report generation module 20. The preset factor evaluation such as smoking condition, infection condition and the like can be set according to clinical experience.
For the derivation of the suggestion, the result analysis module 30 may refer to the corresponding relationship between the clinical reason and the suggestion, and then give the corresponding suggestion after the corresponding reason is derived. For example, clinical pharmaceutical recommendations include:
1. when the dosage needs to be adjusted: it is recommended to increase/decrease the dose administered in combination with the clinical symptoms of the patient so that the blood concentration of the drug is controlled within the therapeutic reference concentration range. The plasma concentrations were re-measured about 7 days after dose adjustment (exception with long half-life drugs such as fluoxetine, aripiprazole, donepezil, etc.), during which time patient symptom changes and adverse reactions were closely monitored.
2. Patient compliance issues are suspected: the patient medication monitoring is recommended to be enhanced, the blood concentration is closely monitored in the period, the blood concentration is redetermined according to the treatment scheme of the patient after the concentration reaches the steady state, and meanwhile, compliance education is carried out on the patient.
3. Smoking related problems: advising to enhance the patient's health education and gradually reduce the smoking volume. During smoking cessation, the patient's concentration may rise, and blood concentration and adverse reactions are closely monitored, with medication being reduced as necessary.
4. Blood sampling at non-valley concentration: and (4) advising re-measuring the blood concentration and ensuring blood sampling at a steady-state valley concentration, and closely monitoring adverse reactions.
5. Drug-drug interactions (more influential): it is recommended that the affected drug be reduced as quickly as possible to ensure return to within the therapeutic reference concentration range, with minor interaction therapeutic agents being substituted as appropriate.
On the basis of the embodiment, the corresponding to-be-analyzed item is obtained according to the therapeutic drug monitoring and comparing result, the reason analysis result and the suggestion conclusion corresponding to the therapeutic drug monitoring and comparing result are obtained by analyzing the to-be-analyzed item, and the result and the suggestion conclusion are sent to the report generating module, so that the content of the therapeutic drug monitoring result explanation report is enriched, and the standardization of the explanation report is facilitated.
Further, based on the above embodiment, the monitoring and comparing result of the therapeutic agent includes a combined interval relationship of a first interval range obtained by comparing the monitoring result of the therapeutic agent with the therapeutic reference concentration range, the laboratory guarding concentration and the lower detection limit, a second interval range obtained by comparing the dose-related concentration with the dose-related reference concentration range, and a third interval range obtained by comparing the ratio of the metabolite to the parent drug with the ratio of the metabolite to the parent drug; and the items to be analyzed correspond to the interval combination relationship.
The therapeutic monitoring comparison comprises a first range of intervals derived by comparing the therapeutic monitoring to the therapeutic reference concentration range, the laboratory watch concentration, and a lower detection limit. Generally speaking, the laboratory caution concentration > upper limit of the treatment reference concentration range > lower limit of the detection, whereby the first interval obtained by comparing the therapeutic drug monitoring result with the treatment reference concentration range, the laboratory caution concentration and the lower limit of the detection may be in five different value intervals, such as therapeutic drug monitoring result < lower limit of detection, lower limit of detection < therapeutic drug monitoring result < lower limit of treatment reference concentration range, lower limit of treatment reference concentration range < therapeutic drug monitoring result < upper limit of treatment reference concentration range, upper limit of treatment reference concentration range < therapeutic drug monitoring result < laboratory caution concentration, therapeutic drug monitoring result > laboratory caution concentration, each different value interval may be represented by a different letter, such as ABCDE. Similarly, the second interval obtained by comparing the dose-related concentration with the dose-related reference concentration range includes three different value intervals, namely, the dose-related concentration is not less than the lower limit of the dose-related reference concentration range, the dose-related reference concentration is not less than the lower limit of the dose-related reference concentration range, the dose-related concentration is not less than the upper limit of the dose-related reference concentration range, and the dose-related concentration > the upper limit of the dose-related reference concentration range can also be represented by different letters, such as ABC. The third interval range obtained by comparing the ratio of the metabolite to the parent drug with the ratio range of the metabolite to the parent drug also comprises three different value intervals, namely the ratio of the metabolite to the parent drug is less than the lower limit of the ratio range of the metabolite to the parent drug, the lower limit of the ratio range of the metabolite to the parent drug is less than or equal to the upper limit of the ratio range of the metabolite to the parent drug, the ratio of the metabolite to the parent drug is greater than the upper limit of the ratio range of the metabolite to the parent drug, and the third interval range can also be represented by different letters, such as ABC. The first interval range, the second interval range and the third interval range form an interval combination relation, and the interval combination relation shows the value taking condition of each interval range. For example, the sequential combination of three-digit letters is used to represent the interval combination relationship, the first digit represents the value situation of the first interval range, the second digit represents the value situation of the second interval range, and the third digit represents the value situation of the third interval range. If the interval combination relationship is represented as DBB, it can be represented as: the upper limit of the treatment reference concentration range < the monitoring result of the treatment drug < the laboratory warning concentration, the lower limit of the dose-related reference concentration range is less than or equal to the lower limit of the dose-related concentration range is less than or equal to the upper limit of the dose-related reference concentration range, and the ratio of the metabolite to the parent drug is less than or equal to the lower limit of the metabolite-to-parent drug ratio range is less than or equal to the upper limit of the metabolite-to-.
It can be seen that each different interval combination relationship represents different value conditions of the therapeutic drug monitoring comparison result. Therefore, the interval combination relation and the corresponding relation of the items to be analyzed can be stored in the database in advance according to clinical experience. Therefore, after the interval combination relationship is determined according to the first interval range, the second interval range and the third interval range, the corresponding items to be analyzed can be determined according to the value conditions of the interval combination relationship, and the related items to be analyzed can be directly obtained to carry out reason analysis and suggestion, so that the efficiency of explaining the therapeutic drug monitoring results can be greatly improved.
On the basis of the above embodiment, the embodiment of the present invention sets the items to be analyzed to correspond to the interval combination relationship, wherein the interval combination relationship is composed of a first interval range obtained by comparing the therapeutic drug monitoring result with the therapeutic reference concentration range, the laboratory guarding concentration and the detection lower limit, a second interval range obtained by comparing the dose-related concentration with the dose-related reference concentration range, and a third interval range obtained by comparing the ratio of the metabolite to the parent drug with the ratio of the metabolite to the parent drug, thereby greatly improving the efficiency of interpretation of the therapeutic drug monitoring result.
Further, based on the above embodiment, the items to be analyzed include at least one of enzyme metabolism status, test items, compliance issues, drug combination status, historical TDM results, peak concentration, half-life, minimum inhibitory concentration, and drug metabolizing enzyme genotype.
The reason for the common abnormal results of the monitoring results of the therapeutic drugs and the analysis are as follows:
1. problem of blood sampling time
TDM requires the collection of blood samples over a period of analytical interest, typically at steady state trough concentrations, i.e., from the time of multiple doses reaching steady state immediately after dosing to the lowest concentration prior to the next dose. Generally, the concentration of the medicine before the last administration after 5-7 half-lives of the medicine is taken is adopted. If the patient takes the medicine without reaching the steady state, the blood concentration of the medicine may be lower than the treatment reference concentration range; if the blood sample is taken at a time other than the trough concentration time point, the measured blood concentration is likely to be higher than the therapeutic reference concentration range. In addition, if the patient takes the medicine before blood sampling, the blood concentration can also be greatly higher than the treatment reference concentration range.
2. Problem of combined medication
Most neuropsychiatric drugs are metabolized by the liver, with only a small proportion being metabolized in extrahepatic tissues, such as the small intestinal mucosa or brain tissue. Pharmacokinetic drug interactions may occur when the drug used in combination is an inhibitor or inducer of a drug metabolizing enzyme and the monitored drug is a substrate for the inhibited or induced enzyme. Generally, when the drug to be used in combination is an inhibitor of a drug-metabolizing enzyme, the concentration of the drug metabolized by the enzyme will increase, whereas when the drug to be used in combination is an inducer of the drug-metabolizing enzyme, the concentration of the drug metabolized by the enzyme will decrease.
3. Smoking
Smoking is the most clinically relevant of the many environmental factors when the drug is administered as a substrate for the CYP1a2 enzyme. CYP1A2 enzyme can be induced by polycyclic aromatic hydrocarbon components in tobacco, and the induction is dose-dependent. The activity of the CYP1A2 enzyme increased 1.2, 1.5, and 1.7 fold when smoking 1-5, 6-10, and >10 cigarettes per day, respectively. After 3 days of smoking cessation, the activity of the enzyme was restored to baseline levels. Therefore, when the administered drug (e.g., clozapine, duloxetine, mirtazapine, olanzapine, etc.) is metabolized by the CYP1a2 enzyme, and the patient's smoking amount is greatly changed, the blood concentration is likely to fluctuate. Therefore, for the abnormal blood concentration of the patients, the effect of smoking must be considered, especially when the smoking amount is more than 10 cigarettes per day. The dosing should be changed under TDM guidance when the smoke volume changes significantly.
4. Compliance problems
Compliance is an important factor affecting blood levels. Patients often fail to achieve effective therapeutic concentrations because of poor compliance. If the patient takes the medicine for one or more times, the blood concentration of the medicine is reduced and even is lower than the lower detection limit. If the patient has a history of poor compliance, close attention needs to be paid to the blood concentration. When the blood concentration is abnormal for a certain time, the possibility of medicine leakage is considered firstly.
5. Whether or not there is infection
When a patient is inflamed or infected, the metabolism of clozapine, olanzapine and risperidone in the liver can be hindered, so that the concentration of the parent drug of the drugs is increased. Although C-reactive protein (CRP) is poorly specific, elevation of CRP often indicates complications with inflammation or infection in patients, excluding the effects of other factors. When the blood concentration of the patient is increased by using the three medicines, and infection and inflammation exist, the influence of the infection and inflammation on the blood concentration needs to be considered. Inflammation and infection may also lead to elevated concentrations of other psychotropic drugs, three of which are clinically observed or have been reported in the literature.
6. Organic lesions
Intra-and inter-individual variations in neuropsychiatric drug plasma levels (e.g., pharmacokinetic variations) are primarily due to differences in the activity of drug metabolizing enzymes. The enzyme activity decreases with age and is also affected by liver and kidney diseases. Most neuropsychiatric drugs are metabolized by phase I enzymes, and therefore, when liver function is incomplete, the metabolic capability of the drugs eliminated by liver metabolism is weakened, and the drugs are accumulated in the body, resulting in an increase in blood concentration. When kidney function is incomplete, renal clearance is often reduced, drug excretion through the kidney is reduced, and drug accumulates in the body, resulting in an increase in blood concentration. Increased renal clearance, increased activity of CYP 2a6, 2C9, 2D6, and 3a4, as well as uridine diphosphate glucuronosyltransferase (UGT)1a4 and 2B 7; and reduced CYP1A2 and CYP2C19, as well as N-acetyltransferase 2(NAT2) activity; and vice versa. Therefore, attention is paid to the change in blood concentration with the use of the drug metabolized by the above-mentioned drug metabolizing enzyme.
7. Other unexplained fast or slow metabolic phenotypes
There are genetic polymorphisms in drug metabolizing enzymes, particularly CYP isozymes. The gene polymorphism of drug metabolizing enzyme has important clinical significance. On the one hand, slow metabolizers lead to an increase in the concentration of the parent drug due to a slowing of drug metabolism; on the other hand, fast metabolizers decrease the concentration of the parent drug because of the faster metabolism of the drug. Thus, when the blood level is abnormal, reference may be made to the concentration within the expected dose-related reference concentration range, and the patient may be considered to be either a fast or a slow metabolizer when other reasons are excluded.
The item to be analyzed may include at least one of an enzyme metabolism condition, a test item, a compliance problem, a combined medication condition, a historical TDM result, a peak concentration, a half-life, a minimum inhibitory concentration, and a drug metabolizing enzyme genotype according to circumstances.
On the basis of the above embodiments, the embodiments of the present invention improve the normativity and accuracy of the comparative results of monitoring therapeutic drugs by making the items to be analyzed include at least one of enzyme metabolism status, test items, compliance issues, drug combination status, historical TDM results, peak concentration, half-life, minimum inhibitory concentration, and drug metabolizing enzyme genotype.
Further, based on the above embodiment, the preset report template includes at least one of a standard statement field, a therapeutic drug monitoring comparison result description field, a therapeutic drug monitoring comparison result reason description field, and a recommendation description field; wherein, the therapeutic drug monitoring and comparing result description field comprises a preset reference concentration range field and a relation description field.
The standard statement field, for example, a field in the preset report template, which can fixedly output related content, includes "blood concentration of patient is within the treatment reference concentration range" when the monitoring result of the therapeutic drug is within the treatment reference concentration range; the reason description field of the therapeutic drug monitoring comparison result is used for reason analysis of the therapeutic drug monitoring comparison result, and the report generation module can automatically fill corresponding contents according to the reason analysis result obtained by the result analysis module. The suggestion description field is used for giving pharmaceutical suggestions according to the corresponding therapeutic drug monitoring comparison result, and the report generation module can automatically fill corresponding contents according to the suggestion conclusion obtained by the result analysis module. The therapeutic drug monitoring comparison result description field may include one or more. The therapeutic drug monitoring and comparing result description field comprises a preset reference concentration field and a relation description field. The preset reference concentration field is used for describing information of the preset reference concentration, such as a treatment reference concentration range, a dose-related reference concentration range and the like. The relation description field is used for describing the comparison condition of the therapeutic drug monitoring result and the preset reference concentration, such as that the value is greater than, less than or within … … according to the condition of the therapeutic drug monitoring comparison result. Where the ellipses are the information of the relevant preset reference concentrations.
The following are examples of preset report templates:
1. the results were within the therapeutic reference concentration range
The blood concentration of the patient is within a therapeutic reference concentration range, above/below/within a dose-related reference concentration range, above/below/within a metabolite/parent drug ratio range.Reason for. Recommendation _____.
2. Higher than the warning concentration
The blood concentration of the patient is above the alert concentration, above/below/within the therapeutic reference concentration range, above/below/within the dose-related reference concentration range, above/below/within the metabolite/parent drug ratio range.Reason for. AdvisingImmediately reduce the dose or Stopping taking medicine, supplying fluid infusion for symptomatic treatment, measuring blood concentration again according to needs, and closely monitoring symptom change。
3. Above the therapeutic reference concentration range and below the warning concentration
The blood concentration of the patient is above the therapeutic reference concentration range, above/below/within the dose-related reference concentration range, above/below/within the metabolite/parent drug ratio range.Reason for. Recommendation _____.
4. Below a therapeutic reference concentration range
The patient's blood drug level is below the therapeutic reference concentration range, above/below/within the dose-related reference concentration range, above/below/within the metabolite/parent drug ratio range.Reason for. Recommendation _____.
5. Is lower than the detection limit
The blood concentration of the patient is lower than the detection limit.Patients may have poor compliance, no medication/wrong blood concentration measurements Item. Advising compliance issues to be eliminatedRe-detection。
It should be noted that the template of the preset report is not limited to the above contents and formats, and can be flexibly adjusted according to actual needs.
On the basis of the embodiment, the embodiment of the invention further standardizes and enriches the explanation report of the monitoring result of the therapeutic drugs by setting the preset report template comprising the standard statement field, the reason description field of the monitoring and comparing result of the therapeutic drugs, the suggestion description field and at least one description field of the monitoring and comparing result of the therapeutic drugs.
Further, based on the above embodiment, the report generating module 20 is specifically configured to: acquiring the preset report template corresponding to the therapeutic drug monitoring comparison result; if the therapeutic drug monitoring comparison result comprises a therapeutic drug monitoring comparison result description field, determining the relation description field according to the therapeutic drug monitoring comparison result, and determining the therapeutic drug monitoring comparison result description field according to the preset reference concentration range field and the relation description field; if the therapeutic drug monitoring comparison result comprises a therapeutic drug monitoring comparison result reason description field, determining the therapeutic drug monitoring comparison result reason description field according to the reason analysis result; if the therapeutic drug monitoring comparison result comprises a recommendation description field, determining the recommendation description field according to the recommendation conclusion; and finally, automatically generating the therapeutic drug monitoring result explanation report according to the preset sequence among the fields in the preset report template.
The report generating module 20 is configured to generate a therapeutic drug monitoring result interpretation report according to the therapeutic drug monitoring comparison result and a preset report template. The report generating module 20 is specifically configured to, when being configured to generate a therapeutic drug monitoring result interpretation report according to the therapeutic drug monitoring comparison result and a preset report template: firstly, acquiring the preset report template corresponding to the therapeutic drug monitoring and comparing result, wherein after the preset report template is acquired, the content of a standard statement field can be directly acquired, a preset reference concentration field in a therapeutic drug monitoring and comparing result description field can also be directly acquired, a therapeutic drug monitoring and comparing result reason description field and a suggestion description field can be automatically generated according to a reason analysis result and a suggestion conclusion obtained by analysis of a result analysis module, and a relation description field in the therapeutic drug monitoring and comparing result description field can be obtained according to a therapeutic drug monitoring result and a preset reference concentration comparison result; and then, automatically generating the therapeutic drug monitoring result explanation report according to the preset sequence among the fields in the preset report template.
If the relationship description field is "greater than" or "less than", the relationship description field precedes the preset reference density field, and if the relationship description field is "within … …", the ellipsis is the preset reference density field.
If a patient takes risperidone 4mg every day, the concentration of risperidone in vivo is 4.2ng/ml, the concentration of active metabolite paliperidone is 15.2ng/ml, the total concentration of components with pharmacological activity in vivo is 19.4ng/ml, and the ratio of the metabolite to the parent drug is 3.61; the treatment reference concentration range is 20-60 ng/ml, the lower detection limit is 2.5mg/ml, the dose-related reference concentration range is 14.16-28.96 ng/ml, and the normal range of the ratio of the metabolite to the parent drug is 3.6-22.7. Therefore, the therapeutic monitoring comparison result of the patient belongs to the case of being lower than the therapeutic reference concentration range, and the therapeutic monitoring result interpretation report can include the following contents:
the blood concentration of the patient is below the therapeutic reference concentration range, within the dose-related reference concentration range, within the metabolite/parent drug ratio range.
The reason is as follows: in conjunction with the patient TDM-related data, the reason for the current concentration abnormality in the patient is likely due to the lower dose.
And (4) proposing: it is recommended to adjust the administration dosage or continue monitoring as appropriate in combination with the clinical actual condition of the patient so that the blood concentration is controlled within the therapeutic reference concentration range. The fixed dose is adjusted for about 5 days, then the blood concentration is measured in a selective and repeated mode, and the symptom change and the adverse reaction are closely monitored in the period.
On the basis of the above embodiment, the embodiment of the present invention improves the automation degree and the standardization degree of the generation of the therapeutic drug monitoring result interpretation report by acquiring each field in the preset report template and automatically generating the therapeutic drug monitoring result interpretation report according to the preset sequence among each field.
Further, based on the above embodiment, the system further includes a patient information obtaining module 40, where the patient information obtaining module 40 is configured to obtain patient-related information related to the item to be analyzed, and provide the patient-related information to the result analysis module 30 for analysis.
The result analysis module 30 needs to analyze the reason and suggest the result of the monitoring and comparing of the therapeutic drug according to the relevant information of the patient. The patient-related information may be acquired by the patient information acquisition module 40 and sent to the outcome analysis module 30. The patient information obtaining module 40 may obtain the patient-related information through an API interface of the HIS system.
Some examples of patient-related information are given below:
1. necessary information
In order to determine the cause of the abnormal blood concentration of the patient by combining with the TDM result analysis, the following information can be collected to assist the determination: the medicine taking article rule, the usage amount, the medicine taking course, the liver and kidney function state, the immune function state, the behavior history (diet, smoking and drinking) of the medicine taking and influencing pharmacokinetics, the last medicine taking time, the compliance, the peak concentration, the medicine metabolic enzyme genotype, the previous blood concentration result, the contact way and the like are combined. The dosage form and specification, the dosage and the course of medication of the drug directly influence the pharmacokinetic process of the drug; the liver and kidney function state and the immune function state of the organism of a patient influence the blood concentration of the medicine by influencing the absorption, distribution, metabolism and excretion of the medicine in the human body; the combined actions of the patient such as medication, smoking and drinking history and the like can possibly interact with the medicine, thereby influencing the blood concentration of the medicine; the last adjustment dosing time and the last dosing time may be used to calculate the patient's theoretical steady-state trough concentration; the patient medication compliance information can eliminate abnormal blood concentration caused by the fact that the patient fails to follow the medical advice to take the medicine; patient contact information is collected to contact the patient for follow-up.
2. Unnecessary information
Other collectible information includes: other demographic information, diagnosis, disease severity, treatment effect improvement, adverse reactions, application for doctors, etc. of patients, so as to carry out statistics summary, drug safety and effectiveness analysis, etc. But collecting this information in detail may be helpful in interpreting some cases of distress.
On the basis of the embodiment, the embodiment of the invention acquires the relevant information of the patient through the patient information acquisition module, thereby ensuring that the reason analysis and the corresponding suggestion are smoothly carried out by the result analysis module.
Further, based on the above embodiment, the report generating module 20 is further configured to output a preset standard speech segment when the monitoring result of the therapeutic agent is not the steady-state concentration and other preset conditions.
When the therapeutic drug monitoring result is not in steady-state concentration, the reliability of the therapeutic drug monitoring result is poor, no further calculation of the ratio of the metabolite to the parent drug can be performed, and at the moment, a preset standard speech section can be directly output in the therapeutic drug monitoring result explanation report, such as: if the therapeutic drug monitoring result is not at the steady-state concentration, please retrieve the therapeutic drug monitoring result at the steady-state concentration, and so on.
It can be understood that preset standard language segments output under other conditions can be set according to needs.
On the basis of the above embodiment, the embodiment of the present invention enriches the interpretation report of the therapeutic drug monitoring result by outputting the preset standard speech segment when the therapeutic drug monitoring result is not the steady-state concentration or other preset conditions.
Fig. 3 is a schematic view of a drug monitoring result interpretation process of the therapeutic drug monitoring result interpretation system according to an embodiment of the present invention. As shown in fig. 3, if the TDM result is higher than the laboratory warning concentration, which is a condition requiring immediate processing, a report is written according to the template; if the TDM result is within the treatment reference concentration range and within the dose-related concentration range, a report is written according to the template for a normal result. If the TDM result is not in the treatment reference concentration range and/or not in the dose-related concentration range, further judging whether the TDM result is in a steady-state valley concentration, if so, further calculating the ratio of the metabolites to the parent drugs for the drugs with the MPR, judging according to the combined information, determining the items to be analyzed, collecting and verifying information, such as analyzing demographic data, analyzing combined medication, analyzing biochemical indexes, analyzing historical TDM, and the like, and then writing a report according to a template by combining the analysis result. If the TDM result is judged not to be the steady-state valley concentration, a report is written according to the template.
The above-described embodiments of the apparatus are merely illustrative, and the units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units, may be located in one place, or may be distributed on a plurality of network units. Some or all of the modules may be selected according to actual needs to achieve the purpose of the solution of the present embodiment. One of ordinary skill in the art can understand and implement it without inventive effort.
Through the above description of the embodiments, those skilled in the art will clearly understand that each embodiment can be implemented by software plus a necessary general hardware platform, and certainly can also be implemented by hardware. Based on the understanding, the above technical solutions may be essentially or partially implemented in the form of a software product, which may be stored in a computer-readable storage medium, such as ROM/RAM, magnetic disk, optical disk, etc., and includes several instructions for enabling a computer device (which may be any intelligent device capable of collecting, analyzing and feeding back information, such as a personal computer, a mobile terminal, a wearable device, an implantable device, a server, or a network device) to execute the method according to each embodiment or some parts of the embodiments.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (10)
1. A therapeutic monitoring result interpretation system, comprising:
a comparison and judgment module, configured to: comparing the therapeutic agent monitoring result with at least one preset first reference concentration range; and/or obtaining at least one preset statistical result according to the therapeutic drug monitoring result, and comparing the preset statistical result with a corresponding preset second reference concentration range to obtain a therapeutic drug monitoring comparison result;
a report generation module to: and generating a therapeutic drug monitoring result interpretation report according to the therapeutic drug monitoring comparison result and a corresponding preset report template.
2. The therapeutic monitoring result interpretation system of claim 1, wherein the preset first reference concentration range comprises a therapeutic reference concentration range and a laboratory watch concentration; the preset statistical result comprises dose-related concentration, and the preset second reference concentration range corresponding to the dose-related concentration is a dose-related reference concentration range.
3. The system of claim 2, wherein the comparison determination module, prior to being configured to obtain the comparison result, is further configured to:
and if the therapeutic drug monitoring result is judged to be not in the therapeutic reference concentration range and/or the dose-related concentration is not in the dose-related reference concentration range, judging whether the therapeutic drug monitoring result is a steady-state concentration, if so, further calculating a ratio of the metabolite to the parent drug according to the therapeutic drug monitoring result, and comparing the ratio of the metabolite to the parent drug with the ratio range of the metabolite to the parent drug.
4. The therapeutic monitoring results interpretation system of claim 3, wherein the system further comprises a results analysis module; the comparison and judgment module is also used for sending the therapeutic drug monitoring and comparison result to the result analysis module; the result analysis module is used for acquiring a corresponding item to be analyzed according to the therapeutic drug monitoring and comparing result, analyzing the item to be analyzed to obtain a reason analysis result and a suggestion conclusion corresponding to the therapeutic drug monitoring and comparing result, and sending the reason analysis result and the suggestion conclusion to the report generation module.
5. The system according to claim 4, wherein the monitoring comparison result of therapeutic agent comprises a combination of intervals consisting of a first interval range obtained by comparing the monitoring result of therapeutic agent with the therapeutic reference concentration range, the laboratory warning concentration and a lower detection limit, a second interval range obtained by comparing the dose-related concentration with the dose-related reference concentration range, and a third interval range obtained by comparing the metabolite-to-parent agent ratio with the metabolite-to-parent agent ratio range; and the items to be analyzed correspond to the interval combination relationship.
6. The therapeutic drug monitoring result interpretation system according to claim 5, wherein the items to be analyzed include at least one of enzyme metabolism status, test items, compliance issues, drug combination status, historical TDM results, peak concentration, half-life, minimum inhibitory concentration, drug metabolizing enzyme genotype.
7. The system according to claim 4, wherein the preset report template comprises at least one of a standard sentence field, a therapeutic drug monitoring comparison result description field, a therapeutic drug monitoring comparison result reason description field, and a recommendation description field; wherein, the therapeutic drug monitoring and comparing result description field comprises a preset reference concentration range field and a relation description field.
8. The system of claim 7, wherein the report generation module is specifically configured to:
acquiring the preset report template corresponding to the therapeutic drug monitoring comparison result; if the therapeutic drug monitoring comparison result comprises a therapeutic drug monitoring comparison result description field, determining the relation description field according to the therapeutic drug monitoring comparison result, and determining the therapeutic drug monitoring comparison result description field according to the preset reference concentration range field and the relation description field; if the therapeutic drug monitoring comparison result comprises a therapeutic drug monitoring comparison result reason description field, determining the therapeutic drug monitoring comparison result reason description field according to the reason analysis result; if the therapeutic drug monitoring comparison result comprises a recommendation description field, determining the recommendation description field according to the recommendation conclusion; and finally, automatically generating the therapeutic drug monitoring result explanation report according to the preset sequence among the fields in the preset report template.
9. The system as claimed in claim 4, further comprising a patient information acquisition module for acquiring the patient-related information related to the item to be analyzed and providing the information to the result analysis module for analysis.
10. The system according to claim 3, wherein the report generating module is further configured to output a preset standard speech segment when the monitoring result of the therapeutic agent is not at steady-state concentration or other preset condition.
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| CN114420244A (en) * | 2022-02-28 | 2022-04-29 | 北京大学第三医院（北京大学第三临床医学院） | Medication analysis method and device for Parkinson disease patient |
| CN115295118A (en) * | 2022-10-09 | 2022-11-04 | 江苏南通鼎顺网络科技有限责任公司 | Dispensing data processing system for patient dispensing |
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110224910A1 (en) * | 2010-02-11 | 2011-09-15 | Ameritox, Ltd. | Methods of normalizing measured drug concentrations and testing for non-compliance with a drug treatment regimen |
| CN104520857A (en) * | 2012-06-05 | 2015-04-15 | 德克斯康公司 | Systems and methods for processing analyte data and generating reports |
| CN104884029A (en) * | 2012-10-23 | 2015-09-02 | 赛拉诺斯股份有限公司 | Drug monitoring and regulation systems and methods |
| US20160041146A1 (en) * | 2014-08-11 | 2016-02-11 | Ameritox, Ltd. | Methods of normalizing the ratio of measured parent and metabolite drug concentrations in fluids and testing for non-compliance |
| CN105335616A (en) * | 2015-11-02 | 2016-02-17 | 北京大学第一医院 | Child vancomycin individualized concentration prediction system |
| CN105457123A (en) * | 2015-11-26 | 2016-04-06 | 北京大学第一医院 | Medicine use control system of large-dosage methotrexate |
| US20160335412A1 (en) * | 2013-01-30 | 2016-11-17 | Geoffrey Tucker | Systems and methods for predicting and adjusting the dosage of medicines in individual patients |
| CN108648792A (en) * | 2018-05-04 | 2018-10-12 | 河北省人民医院 | Medication information management system, method and terminal device |
-
2020
- 2020-04-02 CN CN202010256613.7A patent/CN111489822A/en active Pending
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110224910A1 (en) * | 2010-02-11 | 2011-09-15 | Ameritox, Ltd. | Methods of normalizing measured drug concentrations and testing for non-compliance with a drug treatment regimen |
| CN104520857A (en) * | 2012-06-05 | 2015-04-15 | 德克斯康公司 | Systems and methods for processing analyte data and generating reports |
| CN104884029A (en) * | 2012-10-23 | 2015-09-02 | 赛拉诺斯股份有限公司 | Drug monitoring and regulation systems and methods |
| US20160335412A1 (en) * | 2013-01-30 | 2016-11-17 | Geoffrey Tucker | Systems and methods for predicting and adjusting the dosage of medicines in individual patients |
| US20160041146A1 (en) * | 2014-08-11 | 2016-02-11 | Ameritox, Ltd. | Methods of normalizing the ratio of measured parent and metabolite drug concentrations in fluids and testing for non-compliance |
| CN105335616A (en) * | 2015-11-02 | 2016-02-17 | 北京大学第一医院 | Child vancomycin individualized concentration prediction system |
| CN105457123A (en) * | 2015-11-26 | 2016-04-06 | 北京大学第一医院 | Medicine use control system of large-dosage methotrexate |
| CN108648792A (en) * | 2018-05-04 | 2018-10-12 | 河北省人民医院 | Medication information management system, method and terminal device |
Non-Patent Citations (1)
| Title |
|---|
| 李樱 等: "精神分裂症患者血清、血浆、红细胞内氯氮平及其代谢物浓度的研究", 《中华精神科杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114420244A (en) * | 2022-02-28 | 2022-04-29 | 北京大学第三医院（北京大学第三临床医学院） | Medication analysis method and device for Parkinson disease patient |
| CN115295118A (en) * | 2022-10-09 | 2022-11-04 | 江苏南通鼎顺网络科技有限责任公司 | Dispensing data processing system for patient dispensing |
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Inventor after: Wang Gang Inventor after: Guo Wei Inventor after: Niu Mengxi Inventor after: Zang Yannan Inventor after: Lan Xiaoqian Inventor after: Bao Shuang Inventor after: Jia Fei Inventor after: Zhuang Hongyan Inventor after: Liu Shanshan Inventor before: Guo Wei Inventor before: Niu Mengxi Inventor before: Zang Yannan Inventor before: Lan Xiaoqian Inventor before: Bao Shuang Inventor before: Jia Fei Inventor before: Zhuang Hongyan Inventor before: Liu Shanshan Inventor before: Wang Gang |